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ParaGard T 380A Copper 313.4 mg Intrauterine Device, 1 pouch — NDC 59365-5129-1 (Billing 59365-5129-01)

by CooperSurgical, Inc. · 1 POUCH in 1 CARTON / 1 INTRAUTERINE DEVICE in 1 POUCH

This is a package of 1 pouch of ParaGard T 380A Copper 313.4 mg Intrauterine Device from CooperSurgical, Inc., marketed since Aug 2024 and currently FDA-listed. It is this product's only package size.

NDC 59365-5129-01
🏷️ FDA NDC (as labeled) 59365-5129-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 59365-5129-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59365 labeler · 5129 product · 1 package
Package marketed since
Aug 15, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 5936551291 9
Medicaid fills, this package
14,465 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59365-5129-1
Product NDC 59365-5129
11-digit billing NDC 59365512901
NCPDP billing unit EA — each (per item)
RxCUI 2267305, 2267310
UNII 789U1901C5
Application # NDA018680
SPL Set ID 3c420b53-c95e-46af-aebd-73741be58391
Established class (EPC) Copper-containing Intrauterine Device
Physiologic effect Decreased Embryonic Implantation; Decreased Sperm Motility; Inhibit Ovum Fertilization
Chemical class Copper
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-15
Route INTRAUTERINE
Dosage form INTRAUTERINE DEVICE
Substance COPPER

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 25050010005320
GCN Seq No 071203
GCN 34932
HICL code 000755
Ingredient (HICL) Copper
HIC1 code X
Therapeutic class — broad (HIC1) Medical Supplies And Devices
HIC2 code X1
Therapeutic class — intermediate (HIC2) Reproductive System Agents
HIC3 code X1C
Therapeutic class — specific (HIC3) Intra-Uterine Devices (Iuds)
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name PARAGARD T 380A IUD(SNGL HAND)
FDB brand name Paragard T 380A (Single Hand)
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 071203
  • GCN: 34932
  • GPI-14 (Medi-Span): 25050010005320
  • HICL (First Databank): 000755
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 2267305
Why two NDCs? The FDA registers this code as 59365-5129-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 59365-5129-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Copper-containing Intrauterine Device class.

Pharmacologic class Copper-containing Intrauterine Device
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PARAGARD T 380A IUD(SNGL HAND) Ingredient Copper

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1,049.08 $1,049.08 / 1 intrauterine
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59365-5129-01 You're viewing this Main listing 1 POUCH in 1 CARTON / 1 INTRAUTERINE DEVICE in 1 POUCH 2024-08-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ParaGard T 380A 313.4 mg 59365-5128-01 CooperSurgical, 1 pouch — — FDA listed —
ParaGard T 380A 313.4 mgthis 59365-5129-01 CooperSurgical, 1 pouch — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1984
First FDA approval
Nov 1984
📍
2026
Currently FDA-listed
42 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 15, 1984 RLD RS ⏳ ~0.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity D-193
1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
D-193Other change requiring clinical data (3-year)Jun 28, 2027
Common questions
Is there a generic version of PARAGARD T 380A IUD(SNGL HAND)?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for PARAGARD T 380A IUD(SNGL HAND). Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2027 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 25BB7EKE2E
    Barium sulfate is a white powder mineral compound used as a filler and opacifying agent in tablets and capsules. It adds bulk to the medicine and may be included in formulations for imaging purposes.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCooperSurgical, Inc.
Application holderCOOPERSURGICAL INC
FDA applicationNDA018680 (NDA)
Labeler code59365
First marketedAug 2024
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from CooperSurgical, Inc. labeler code 59365

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Insert a single Paragard at the fundus of the uterine cavity. Remove Paragard no later than 10 years from the date of insertion. ( 2.1 ) Insert and remove Paragard only if you are a healthcare provider trained on these procedures.

( 2.1 ) See the Full Prescribing Information for recommended timing of insertion preparation instructions, insertion procedures, postplacement management, and instructions on removing Paragard. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Following the insertion, examine the patient after her first menses to confirm Paragard is still in place. ( 2.5 ) Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9

2.1Important Dosage and Administration Instructions Paragard should only be inserted by a healthcare provider trained in Paragard’s insertion procedures, because insertion for Paragard is different from that used for other intrauterine systems. Healthcare providers should become thoroughly familiar with the product, product educational materials, product insertion instructions, and prescribing information before attempting insertion of Paragard. Insert one Paragard at the fundus of the uterine cavity [see Dosage and Administration ( 2.4 )].

Remove Paragard on or before 10 years from the date of insertion [see Dosage and Administration ( 2.6 )]. May replace Paragard at the time of removal with a new Paragard if continued contraceptive protection is desired. Before considering use of Paragard, make sure that the female is an appropriate candidate for Paragard.

Exclude pregnancy (consider the possibility of ovulation and conception) prior to use [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )].

2.2Timing of Insertion Refer to Table 1 for recommended timing of Paragard insertion. Table 1: Recommended Timing of Paragard Insertion Clinical Situation Recommended Timing of Paragard Insertion 1. Start Paragard in females not currently using contraception At any time during the menstrual cycle.

2. Switch to Paragard from an oral, transdermal, or vaginal form of hormonal contraception or an injectable progestin contraceptive At any time during the menstrual cycle; discontinue the previous method. 3.

Switch to Paragard from a contraceptive implant or other intrauterine system Same day the implant or IUS is removed (insert at any time during the menstrual cycle). 4. Insert Paragard after abortion or miscarriage Immediately after abortion, although immediate placement has a slightly higher risk of expulsion than placement at other times.

Insertion after second trimester abortion is associated with a higher risk of expulsion than insertion after a first trimester abortion. 5. Insert Paragard after Childbirth May insert immediately postpartum.

Insertion before uterine involution is complete, which may not occur until the second postpartum month, has been associated with increased risk of expulsion [see Warnings and Precautions ( 5.6 , 5.7 )] . There appears to be an increased risk of perforation in lactating women [see Warnings and Precautions ( 5.6 )]. Note: The inserter provided with Paragard (see Figure 1) and the Insertion Procedure described in subsection 2.4 are not applicable for immediate insertion after childbirth.

For immediate insertion post childbirth, remove the inserter and Paragard from the tray, move the button forward and then completely back to release the Paragard unit from the inserter and insert Paragard.

2.3Preparation Instructions Read the Preparation Instructions and Insertion Procedure before initiating Paragard insertion . Before insertion: Do NOT remove the inserter from the tray before the arms are loaded into the insertion tube. The tray will be used to fold the Paragard arms down and load the IUS into the inserter.

Use strict aseptic techniques throughout preparation [see Warnings and Precautions ( 5.4 )]. Prepare placement tools (e.g., speculum, cotton swab, tenaculum, uterine sound, scissors, and forceps). Consider use of… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 191 words ▾

3 DOSAGE FORMS AND STRENGTHS Paragard is a T-frame copper-containing intrauterine system (IUS) consisting of a polyethylene frame with barium sulfate measuring 32 mm horizontally and 36 mm vertically, with approximately 176 mg of copper wire wrapped around the vertical stem and an approximately 68.7 mg copper wire collar placed on each side of the horizontal arm with a total exposed copper surface area is 380 ± 23 mm ² , packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray. A monofilament polyethylene thread is tied through the tip of the vertical stem resulting in two white threads, each approximately 36.5 cm in length.

Figure 1 displays the contents of the package [see Dosage and Administration ( 2.3 )]. One sterile, T-frame IUS containing copper consisting of a T-shaped polyethylene frame with a total exposed copper surface area of 380 ± 23 mm², (approximately 176 mg of wire wrapped around the vertical stem and an approximately 68.7 mg collar placed on each side of the horizontal arm) packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray. ( 3 , 16 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS The use of Paragard is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.1 , 5.2 ) and Use in Specific Populations ( 8.1 )] Abnormalities of the uterus resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and Precautions ( 5.4 )] Postpartum endometritis or postabortal endometritis in the past 3 months [see Warnings and Precautions ( 5.4 )] Known or suspected uterine or cervical malignancy Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis or other lower genital tract infection Conditions associated with increased susceptibility to pelvic infections [see Warnings and Precautions ( 5.4 )] Wilson’s disease [see Warnings and Precautions ( 5.8 )] A previously placed IUD or IUS that has not been removed Hypersensitivity to any component of Paragard including to copper or any of the trace elements present in the copper component of Paragard [see Adverse Reactions ( 6.2 ) and Description ( 11 )] Pregnancy or suspicion of pregnancy ( 4 ) Abnormalities of the uterus resulting in distortion of the uterine cavity ( 4 ) Acute pelvic inflammatory disease (PID) ( 4 ) Postpartum endometritis or postabortal endometritis in past 3 months ( 4 ) Known or suspected uterine or cervical malignancy ( 4 ) Uterine bleeding of unknown etiology ( 4 ) Untreated acute cervicitis or vaginitis or other lower genital tract infection ( 4 ) Conditions associated with increased susceptibility to pelvic infections ( 4 ) Wilson’s disease ( 4 ) A previously placed IUD or IUS that has not been removed ( 4 ) Hypersensitivity to any component of Paragard including copper or any trace elements present in the copper components of Paragard ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Ectopic Pregnancy : Promptly evaluate women who become pregnant for ectopic pregnancy while using Paragard. ( 5.1 ) Risks with Intrauterine Pregnancy : Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock and death if pregnancy occurs. Remove Paragard if pregnancy occurs with Paragard in place.

( 5.2 ) Sepsis : Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion ( 5.3 ) Pelvic Inflammatory Disease (PID) and Endometritis : Before using Paragard, consider the risks of PID and endometritis. Promptly assess and treat patients with signs and symptoms of PID. ( 5.4 ) Embedment : Surgical removal may be necessary.

( 5.5 ) Perforation : May reduce contraceptive effectiveness and require surgery. Risk is increased if inserted in lactating women and may be increased if inserted in women with fixed, retroverted uteri or noninvoluted uteri. ( 5.6 ) Expulsion : Partial or complete expulsion may occur.

Remove a partially expelled Paragard. ( 5.7 ) Bleeding patterns : May be altered and result in heavier and longer bleeding with spotting. ( 5.9 ) MRI Safety Information : Patients using Paragard can be safely scanned with MRI only under certain conditions.

( 5.10 ) MR

5.1Ectopic Pregnancy Evaluate for possible ectopic pregnancy in any female who becomes pregnant while using Paragard because a pregnancy that occurs with Paragard in place is more likely to be ectopic than a pregnancy in the general population. However, because Paragard prevents most pregnancies, females who use Paragard have a lower risk of an ectopic pregnancy than sexually active females who do not use any contraception. The incidence of ectopic pregnancy in the clinical trials with Paragard (which excluded females with a previous history of ectopic pregnancy) was approximately 0.06%.

Ectopic pregnancy may require surgery and may result in loss of fertility.

5.2Risks with Intrauterine Pregnancy If intrauterine pregnancy occurs with Paragard in place and the strings are visible or can be retrieved from the cervical canal, remove Paragard because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Paragard may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Paragard, consider the following: Septic Abortion In females becoming pregnant with an intrauterine system (IUS), including Paragard in place, septic abortion, with septicemia, septic shock, and death, may occur [see Warnings and Precautions ( 5.3 )].

Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility.

Continuation of Pregnancy If a female becomes pregnant with Paragard in place and if Paragard cannot be removed or the female chooses not to have it removed, warn her that failure to remove Paragard increases the risk of miscarriage, sepsis, premature labor, and premature delivery. Prenatal care should include counseling about these risks and that she should report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid, or any other symptom that suggests complications of the pregnancy.

5.3Sepsis Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of IUSs, including Paragard. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections.

Aseptic technique during insertion of Paragard is essential in order to minimize serious infections such as GAS [see Dosage and Administration ( 2.3 )]. 5.4… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions ( 5.1 )] Intrauterine pregnancy [see Warnings and Precautions ( 5.2 )] Septic abortion [see Warnings and Precautions ( 5.2 )] Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions ( 5.3 )] Pelvic Inflammatory Disease and Endometritis [see Warnings and Precautions ( 5.4 )] Embedment [see Warnings and Precautions ( 5.5 )] Perforation [see Warnings and Precautions ( 5.6 )] Expulsion [see Warnings and Precautions ( 5.7 )] Bleeding Pattern Alterations [see Warnings and Precautions ( 5.9 ) ] Adverse reactions reported in clinical trials include: anemia, backache, dysmenorrhea, dyspareunia, expulsion (complete or partial), prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CooperSurgical, Inc. at 1-877-727-2427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure in two trials [see Clinical Studies ( 14 )]. The WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the U.S.

In the WHO Study, 100% were parous and the mean age at enrollment was 29 years old. The U.S. Composite Study was a meta-analysis that evaluated randomized, double-blind, comparative studies of copper T IUSs, including Paragard in 3,536 women in the U.S.

In the U.S. Composite Study, 64% were nulliparous, 49% were nulligravida, 68% were under age 25 at the time of enrollment (median age 23 years old). Table 2 shows discontinuation rates from the two clinical studies by adverse reaction and year.

Table 2: Summary of Rates* (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation Year 1 2 3 4 5 6 7 8 9 10 Number of Women at Start of Year 4,932 3,149 2,018 1,121 872 621 563 483 423 325 Expulsion 5.7 2.5 1.6 1.2 0.3 0.0 0.6 1.7 0.2

0.4Bleeding/Pain 11.9 9.8 7.0 3.5 3.7 2.7 3.0 2.5 2.2

3.7Other Medical Event 2.5 2.1 1.6 1.7 0.1 0.3 1.0 0.4 0.7 0.3 *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the U.S. Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials. The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.

Study CSIPD-001 The Paragard inserter that enables single-hand insertion was evaluated in Study CSIPD-001. A total of 117 females of reproductive potential aged 18 to 49 years, underwent Paragard insertion and were followed for up to 12 weeks of Paragard use. Subjects were predominantly white (76%), 45% were parous, and 35% were obese.

Successful placement of Paragard with first attempt occurred in 91% of the subjects and 99% with two insertion attempts. Adverse reactions of special interest occurring during the study were IUS expulsion (2.6%), vasovagal reaction (2.6%), IUS malposition (1.7%), partial uterine perforation (0.9%), and IUS embedment (0.9%).

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of Paragard. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: abdominal distension, nausea General Disorders and Administration Site Conditions: device breakage, pyrexia; copper wire breakage Immune System Disord… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 16 words ▾

7 DRUG INTERACTIONS No drug-drug interaction or drug-herbal supplement interaction studies have been conducted with Paragard.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Use of Paragard is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Paragard may cause adverse pregnancy outcomes. If a female becomes pregnant with Paragard in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 ) ] . Advise the female of the potential risks if pregnancy occurs with Paragard in place.

Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus. Studies on Paragard and birth defects have not been conducted.

8.2Lactation Risk Summary No difference has been detected in concentration of copper in human milk before and after insertion of copper IUSs, including Paragard. There is no information on the effect of copper in a breastfed child or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Paragard and any potential adverse effects on the breastfed child from Paragard.

8.4Pediatric Use The safety and effectiveness of Paragard have been established in females of reproductive potential. Efficacy is expected to be the same for postmenarcheal females regardless of age. Paragard is not indicated in females before menarche.

8.5Geriatric Use Paragard has not been studied in women over 65 years of age and is not indicated in this population.

🤰 Pregnancy 128 words ▾

8.1Pregnancy Risk Summary Use of Paragard is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Paragard may cause adverse pregnancy outcomes. If a female becomes pregnant with Paragard in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 ) ] . Advise the female of the potential risks if pregnancy occurs with Paragard in place.

Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus. Studies on Paragard and birth defects have not been conducted.

🧒 Pediatric Use 38 words ▾

8.4Pediatric Use The safety and effectiveness of Paragard have been established in females of reproductive potential. Efficacy is expected to be the same for postmenarcheal females regardless of age. Paragard is not indicated in females before menarche.

🧓 Geriatric Use 22 words ▾

8.5Geriatric Use Paragard has not been studied in women over 65 years of age and is not indicated in this population.

🧬 Clinical Pharmacology 43 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Copper continuously released into the uterine cavity contributes to the contraceptive effectiveness of Paragard. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg, and possibly prevention of implantation.

🧬 Mechanism of Action 40 words ▾

12.1Mechanism of Action Copper continuously released into the uterine cavity contributes to the contraceptive effectiveness of Paragard. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg, and possibly prevention of implantation.

📦 How Supplied / Storage and Handling 127 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Paragard (intrauterine copper contraceptive) is available in cartons of 1 (one) sterile unit (NDC 59365-5129-1). Each Paragard is white, T-shaped, and measures 32 mm horizontally and 36 mm vertically, with approximately 176 mg of copper wire wrapped around the vertical stem and an approximately 68.7 mg copper wire collar placed on each side of the horizontal arms, and with a monofilament polyethylene thread tied through the tip of the vertical stem [see Dosage and Administration ( 2.3 )].

The T-frame is made of polyethylene with barium sulfate. Each Paragard is packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray and in a Tyvek ® polyethylene pouch. Store at controlled room temperature: 59° to 86°F (15° to 30°C).

📋 Description ~1 min read ▾

11 DESCRIPTION Figure 10 Figure 11

11.1Paragard IUS Paragard (intrauterine copper contraceptive) is a T-shaped intrauterine system (IUS), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. (See Figure 10) [see Dosage and Administration (2.3)]. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each approximately 36.5 cm in length, to aid in detection and removal of the intrauterine system.

The T-frame is made of polyethylene with barium sulfate to aid in detecting the intrauterine system under x-ray. Paragard also contains copper (approximately 176 mg of wire wrapped around the vertical stem and an approximately 68.7 mg collar placed on each side of the horizontal arm). The total exposed copper surface area is 380 ± 23 mm².

One Paragard weighs less than one (1) gram. Figure 10 – Paragard IUS Paragard, its components, and the packaging are not made with natural rubber latex.

11.2Inserter Paragard is packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray and in a Tyvek ® polyethylene pouch. A moveable blue flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity (See Figure 11) [see Dosage and Administration ( 2.3 )]. Figure 11 – Paragard with Inserter

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Before inserting Paragard, counsel patients on the following: Sexually Transmitted Infections : Advise patients that Paragard does not protect against HIV infection and other sexually transmitted diseases. Ectopic Pregnancy : Advise patients to report pregnancies and be evaluated immediately, as a pregnancy with Paragard in place is more likely to be an ectopic pregnancy, and the risks of ectopic pregnancy include the loss of fertility [see Warnings and Precautions ( 5.1 )] .

Intrauterine Pregnancy : Advise patients to report pregnancies and be evaluated immediately, as an intrauterine pregnancy with Paragard in place, may result in septic abortion, with septicemia, septic shock, and possible death. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination.

A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility. If Paragard remains in the uterus during a pregnancy, there is an increased risk of miscarriage, sepsis, premature labor and premature delivery. Advise patients that a pregnancy must be followed closely and advise patients to report immediately any symptom, such as flu- like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leaking of fluid, or any other symptom that suggests complications of the pregnancy [see Warnings and Precautions ( 5.2 )] .

Sepsis : Advise patients that sepsis may occur after insertion of Paragard and to seek immediate treatment for fever and pelvic pain that occurs soon after insertion, as untreated sepsis can result in death [see Warnings and Precautions ( 5.3 )] . Pelvic Inflammatory Disease : Advise patients that pelvic inflammatory disease (PID) may occur after insertion of Paragard and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or can necessitate hysterectomy, or cause death. Advise patients to recognize and report promptly any symptoms of PID including development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever [see Warnings and Precautions ( 5.4 )].

Embedment, Perforation, and Expulsion : Advise patients regarding the risks of embedment, perforation, and expulsion and inform patients that in some cases, removal of Paragard may be difficult and surgical removal may be necessary. Inform patients that perforation can cause infection, scarring, damage to other organs, pain, or infertility. Inform patients that excessive pain or vaginal bleeding during IUS placement, worsening pain or bleeding after placement, or the inability to feel the IUS strings may occur with IUS perforation and expulsion.

There is no protection from pregnancy if Paragard is displaced or expelled [see Warnings and Precautions ( 5.5 , 5.6 , 5.7 ) .] . Bleeding Pattern Alterations : Advise patients that heavier or longer periods and spotting between periods may occur. Instruct patients to report continued or severe symptoms to their healthcare provider [see Warnings and Precautions ( 5.9 )].

Checking for Paragard : Advise patients to check that Paragard is still in the uterus by reaching up to the top of the vagina with clean fingers to feel the two threads. Inform patients not to pull on the threads, which could displace Paragard. Advise patients to promptly report if there are changes in the length of the two threads, if they cannot locate the threads, or they can feel any other part of Paragard besides the threads.

Magnetic Resonance Imaging (MRI) Safety Information : Inform patients that Paragard can be safely scanned with MRI only under specific conditions. Instruct patients who will have an MRI to tell their healthcare provider that they have Para… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The efficacy of Paragard for use in females of reproductive potential for prevention of pregnancy for up to 10 years was demonstrated in two trials: WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the U.S. In the WHO study, 100% were parous and the mean age at enrollment was 29 years old. The U.S.

Composite Study was a meta-analysis that evaluated several randomized, double-blind, comparative studies of copper T IUSs, including the Paragard in 3,536 women in the U.S. In the U.S. study, 64% were nulliparous, 49% were nulligravida; 68% were under age 25 at the time of enrollment (median age 23 years old). The pregnancy rate in the two clinical studies with Paragard was less than 1 pregnancy per 100 women each year (see Table 3).

Table 3: Pregnancy Rates* (Number of Pregnancies per 100 Women) by Year in the WHO and U.S. Studies Year 1 2 3 4 5 6 7 8 9 10 Pregnancy 0.7 0.3 0.6 0.2 0.3 0.2 0.0 0.4 0.0

0.0Number of Women at Start of Year 4,932 3,149 2,018 1,121 872 621 563 483 423 325 *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the U.S. Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials.

🧪 Nonclinical Toxicology 38 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenicity, Mutagenicity, Impairment of Fertility Adequate long-term studies in animals to assess the carcinogenic potential of a copper-containing IUS have not been performed. The genotoxic potential of a copper-containing IUS has not been evaluated.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 35 words ▾

13.1Carcinogenicity, Mutagenicity, Impairment of Fertility Adequate long-term studies in animals to assess the carcinogenic potential of a copper-containing IUS have not been performed. The genotoxic potential of a copper-containing IUS has not been evaluated.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION PARAGARD ® ('par-uh-gahrd) (intrauterine copper contraceptive) Paragard does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs). Read this Patient Information carefully before you decide if Paragard is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women’s health.

If you have any questions about Paragard, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you. What is Paragard?

Paragard is a copper-releasing system that is placed in your uterus by your healthcare provider to prevent pregnancy for up to 10 years. Paragard can be removed by your healthcare provider at any time. Paragard does not contain any hormones.

Paragard can be used whether or not you have given birth to a child. Paragard is a small, flexible plastic “T” shaped intrauterine system with copper wrapped around the stem and placed on arms of the “T”. Two thin white threads are attached to the stem (lower end) of Paragard.

The threads are the only part of Paragard you can feel when Paragard is in your uterus; however, unlike a tampon string, the threads do not extend outside of your body. What if I need birth control for more than 10 years? Paragard must be removed on or before 10 years from the date of insertion.

Your healthcare provider can place a new Paragard during the same office visit if you choose to continue using Paragard. What if I want to stop using Paragard? Paragard is intended for use up to 10 years, but you can stop using Paragard at any time by asking your healthcare provider to remove it.

You could become pregnant as soon as Paragard is removed; however, if you do not want to become pregnant you should use another method of birth control. Talk to your healthcare provider about the best birth control methods for you. What if I change my mind about birth control and want to become pregnant in less than 10 years?

Your healthcare provider can remove Paragard at any time before the 10 years after placement. You may become pregnant as soon as Paragard is removed. How does Paragard work?

Paragard works by preventing sperm from reaching the egg, preventing sperm from fertilizing the egg, or possibly preventing attachment (implantation) in the uterus. Paragard does not stop your ovaries from making an egg (ovulating) each month. How well does Paragard work for contraception?

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart.

The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Paragard, an intrauterine system (IUS), is in the box at the top of the chart. Who might use Paragard?

You might choose Paragard if you: want long-term birth control that provides a low chance of getting pregnant (less than 1 in 100) want birth control that works continuously for up to 10 years want birth control that is reversible want a birth control method that you do not need to take daily are willing to use a birth control method that is inserted in the uterus want birth control that does not contain hormones Do not use Paragard if you: are or might be pregnant have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors have an untreated pelvic infection called pelvic inflammatory disease (PID) now have had an infection in your uterus after a pregnancy or abortion in the past 3 months can get infections easily.

For example, if you: have problems with your immune system have multiple sexual partners or your partner has multiple sexual partners use or abuse intravenous drugs have or suspect you might have cancer of the… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 6 words ▾

Dosing and Administration ( 2 )……………………………………06/2024

📄 Package Label / Principal Display Panel ~1 min read ▾

Principal Display Panel Cooper Surgical® Paragard ® T380A intrauterine copper contraceptive 1 UNIT Each unit wound with approximately 176 mg of copper wire. In addition, a single copper sleeve is swaged on each of the two transverse arms. Each sleeve contains approximately 68.7 mg of copper.

The total surface area of copper on the device is 380 ± 23mm 2 . IMPORTANT: Read the Preparation Instructions and Insertion Procedure before initiating Paragard insertion. To be inserted in the uterus only by a licensed clinician or under the supervision of a physician.

See detailed instructions in the Prescribing Information. NOTE: Patient Information is provided with each unit. Please ensure the Patient Information is provided to and reviewed with each patient before insertion.

Store at controlled room temperature: 59º to 86ºF (15° to 30°C). CooperSurgical, Inc. | 95 Corporate Drive | Trumbull, CT 06611 USA RX ONLY NDC 59365-5129-1 Cooper Surgical® Paragard® T380A intrauterine copper contraceptive 1 UNIT Each unit wound with approximately 176 mg of copper wire. In addition, a single copper sleeve is swaged on each of the two transverse arms.

Each sleeve contains approximately 68.7 mg of copper. The total surface area of copper on the device is 380 ± 23mm2. IMPORTANT: Read the Preparation Instructions and Insertion Procedure before initiating Paragard insertion.

To be inserted in the uterus only by a licensed clinician or under the supervision of a physician. See detailed instructions in the Prescribing Information. NOTE: Patient Information is provided with each unit.

Please ensure the Patient Information is provided to and reviewed with each patient before insertion. Store at controlled room temperature: 59º to 86ºF (15° to 30°C). CooperSurgical, Inc. | 95 Corporate Drive | Trumbull, CT 06611 USA RX ONLY NDC 59365-5129-1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
14.5K
Units reimbursed last 4 qtrs
15.5K
Gross reimbursed last 4 qtrs
$16.31M
Avg / prescription
$1,127.41
Avg / unit
$1,049.08
Latest quarter Q1 2026
3.6KRx
Fee-for-service vs managed care ⓘ
19% FFS 81% MCO
Fee-for-service · 2,728 Rx Managed care · 11,737 Rx
State Medicaid map
Alaska: no data reported AK Maine: 32 units · 2.3 per 100k residents ME Washington: 270 units · 3.5 per 100k residents WA Idaho: 104 units · 5.3 per 100k residents ID Montana: 67 units · 5.9 per 100k residents MT North Dakota: no data reported ND Minnesota: 472 units · 8.2 per 100k residents MN Wisconsin: 224 units · 3.8 per 100k residents WI Michigan: 412 units · 4.1 per 100k residents MI New York: 632 units · 3.2 per 100k residents NY Vermont: 37 units · 5.7 per 100k residents VT New Hampshire: 12 units · 0.9 per 100k residents NH Oregon: 240 units · 5.7 per 100k residents OR Nevada: 137 units · 4.3 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 102 units · 3.2 per 100k residents IA Illinois: 51 units · 0.4 per 100k residents IL Indiana: 416 units · 6.1 per 100k residents IN Ohio: 500 units · 4.2 per 100k residents OH Pennsylvania: 685 units · 5.3 per 100k residents PA New Jersey: 441 units · 4.7 per 100k residents NJ Massachusetts: 441 units · 6.3 per 100k residents MA California: 1,578 units · 4.0 per 100k residents CA Utah: 1,440 units · 42.1 per 100k residents UT Colorado: 231 units · 3.9 per 100k residents CO Nebraska: 35 units · 1.8 per 100k residents NE Missouri: 96 units · 1.5 per 100k residents MO Kentucky: 485 units · 10.7 per 100k residents KY West Virginia: no data reported WV Virginia: 521 units · 6.0 per 100k residents VA Maryland: 491 units · 7.9 per 100k residents MD Connecticut: 200 units · 5.5 per 100k residents CT Rhode Island: no data reported RI Arizona: 334 units · 4.5 per 100k residents AZ New Mexico: 415 units · 19.6 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 522 units · 7.3 per 100k residents TN North Carolina: 930 units · 8.6 per 100k residents NC South Carolina: 86 units · 1.6 per 100k residents SC Delaware: no data reported DE Oklahoma: 105 units · 2.6 per 100k residents OK Louisiana: 183 units · 4.0 per 100k residents LA Mississippi: no data reported MS Alabama: 28 units · 0.5 per 100k residents AL Georgia: 129 units · 1.2 per 100k residents GA D.C.: 13 units · 1.9 per 100k residents DC Hawaii: 149 units · 10.4 per 100k residents HI Texas: 1,666 units · 5.5 per 100k residents TX Florida: 633 units · 2.8 per 100k residents FL
Units reimbursed · per 100k residents
0.442.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Utah 42.1 /100k
2 New Mexico 19.6 /100k
3 Kentucky 10.7 /100k
4 Hawaii 10.4 /100k
5 North Carolina 8.6 /100k
6 Minnesota 8.2 /100k
7 Maryland 7.9 /100k
8 Tennessee 7.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

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What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CooperSurgical, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CooperSurgical, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 59365-5128-01 · CooperSurgical, 59368-0210-01 · Sixarp, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.